M & A: Forensic Regulatory Assessment is Essential
Without It- You Pay for Your Acquisition Over and Over Again Mergers and Acquisitions within the medical device community contribute to the vitality of the industry, but far too many companies only think about forensic accounting as a necessity. All too often the merged company will experience remorse because the due diligence failed to account for systemic regulatory negligence. M & A’s would never occur without forensic financial review. Yet […]
Read More21 CFR 820 for QSR is a US regulation- not an option
These days we read a lot about the US FDA “incorporating” ISO 13485. The US Food and Drug Administration proposed a rule in early 2022 to harmonize its medical device quality management system (QMS) regulation, 21 CFR Part 820, to the ISO 13485 QMS standard. It has not happened yet! Too many folks are over interpreting the FDA intentions; assuming that if their company complies with ISO 13485:2016 they are […]
Read MorePRE-SUB 510(K)*– Yes or No?
Don’t file a Pre-Sub for a 510(k) when you don’t need one. A Pre-Sub for a 510(k) should not be seen as a way to avoid doing your own homework. A Pre-Sub is not without risk and can be time consuming. The potential benefits of receiving feedback to your plans should clearly offset the risk of getting answers you don’t want. There are easier ways to confirm you are on […]
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